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The quest for modernisation of traditional Chinese medicine
Qihe Xu*, Rudolf Bauer, Bruce M Hendry, Tai-Ping Fan, Zhongzhen Zhao, Pierre Duez, Monique SJ Simmonds, Claudia M Witt, Aiping Lu, Nicola Robinson, De-an Guo and Peter J Hylands
Corresponding author:
King's College London, Department of Renal Medicine, London, UK
Institute of Pharmaceutical Sciences, Department of Pharmacognosy, Karl-Franzens-University Graz, Graz, Austria
Department of Pharmacology, University of Cambridge, Cambridge, UK
School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, China
Laboratory of Pharmacognosy, Bromatology and Human Nutrition, Université Libre de Bruxelles, Brussels, Belgium
Royal Botanic Gardens, Kew, Richmond, Surrey, UK
Institute for Social Medicine, Epidemiology and Health Economics, Charité-Universit?tsmedizin, Berlin, Germany
Allied Health Sciences, Faculty of Health and Social Care, London South Bank University, London, UK
Shanghai Research Centre for TCM Modernisation, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, China
King's College London, Institute of Pharmaceutical Science, London, UK
For all author emails, please .
BMC Complementary and Alternative Medicine 2013, 13:132&
doi:10.82-13-132
The electronic version of this article is the complete one and can be found online at:
Received:17 February 2013
Accepted:28 May 2013
Published:13 June 2013
& 2013 Xu et al.; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Traditional Chinese medicine (TCM) is an integral part of mainstream medicine in China.
Due to its worldwide use, potential impact on healthcare and opportunities for new
drug development, TCM is also of great international interest. Recently, a new era
for modernisation of TCM was launched with the successful completion of the Good Practice in Traditional Chinese Medicine Research in the Post-genomic Era (GP-TCM) project, the European Union’s Seventh Framework Programme (FP7) coordination
action on TCM research. This 3.5-year project that involved inputs from over 200 scientists
resulted in the production of 20 editorials and in-depth reviews on different aspects
of TCM that were published in a special issue of Journal of Ethnopharmacology (2012; volume 140, issue 3). In this narrative review, we aim to summarise the findings
of the FP7 GP-TCM project and highlight the relevance of TCM to modern medicine within
a historical and international context. Advances in TCM research since the 1950s can
be characterised into three phases: Phase I (s) was fundamental for developing
TCM higher education, research and hospital networks in C Phase II (s)
was critical for developing legal, economic and scientific foundations and international
networks for TCM; and Phase III (2011 onwards) is concentrating on consolidating the
scientific basis and clinical practice of TCM through interdisciplinary, interregional
and intersectoral collaborations. Taking into account the quality and safety requirements
newly imposed by a globalised market, we especially highlight the scientific evidence
behind TCM, update the most important milestones and pitfalls, and propose integrity, integration and innovation as key principles for further modernisation of TCM. These principles will serve as
foundations for further research and development of TCM, and for its future integration
into tomorrow’s medicine.
Keywords: Evidence- Chi A H S E S I I InnovationIntroduction
Traditional Chinese medicine (TCM) is a holistic medical system for diagnosis, prevention
and treatment of diseases and has been an integral part of Asian cultures for thousands
of years. TCM uses experience-based therapies such as acupuncture and herbal medicine
and is characterised by its underpinning theoretical guide, i.e. the philosophy of
Yin-Yang balance [-]. In a historical and international perspective, this report discusses modernisation
of TCM, an effort to bring the ancient practice of TCM in line with modern scientific
standards []. Focusing on the past 60 years since the 1950s, we aim to highlight the scientific
evidence behind TCM, update the most important milestones and pitfalls, and propose
key principles to guide future developments. Due to the wide range of information
needed for this narrative review, inclusion and exclusion of literature were judged
by co-authors who are experts in the related research area, based on the quality of
work but also on the necessity for illustrating specific research areas. Consensus
was sought among all authors if quality and credibility of any sources of information
were questioned by any co-author.
These past 60 years can be divided into two 30-year phases, which are followed by
a prospective phase III that will be crucial for the scientific prospects of TCM.
o Phase I (s): developing TCM higher education, research and hospital networks
o Phase II (s): developing legal, economic & scientific foundations and
international networks for TCM; and
o Phase III (2011 onwards): further consolidating the scientific basis and clinical
practice of TCM.
Phase I (s)
In response to the open invitation from Premier Zhou Enlai to “come and see” the New
China in the early 1950s, a British Labour Party delegation visited China in 1954
[]. Upon its return, Professor Derrick B. James, the then Lecturer in Anatomy at University
College London, contributed a report to the Lancet under the theme of The Wider World to introduce the ambition of the New China to modernise TCM []. Historically, this seminal article served as an international harbinger of the TCM
modernisation campaign, saying,
“[the] hypothesis is not that Chinese medicine is anachronistic, but that its claims are
worth investigation, so that anything useful it contains may be incorporated into
the body of modern Chinese medical practice” [].
The 1950s were the beginning of China’s efforts to modernise TCM. It was not until
then that China started to build its national networks of TCM universities, hospitals
and research institutes, which laid the structural foundation for modernisation of
TCM. Importantly, China’s ten most prestigious TCM universities and its national TCM
academy were all founded between 1954 and 1960. By the early 1980s, 25 TCM colleges
had been established and the number of beds in TCM hospitals increased by 28.5-fold
from 84,625 in 1949 to 2,412,362 in 1984 [].
With the exception of a few Western scientists like Manfred Porkert, who studied TCM
in China and brought it to the West [], this phase was largely closed to the West due to the Great Leap Forward, the Great
Cultural Revolution and the Cold War. Nevertheless, these thirty years had fundamental
and lasting effects on the modernisation of TCM.
o Collation of case reports and sharing of experience within the TCM community, provision
of TCM knowledge in the curriculum of conventional medical colleges in China and teaching
of modern medicine in TCM colleges paved the way for further development of TCM, as
well as mutual understanding and integration of the two medical traditions [];
o The effect of acupuncture on pain was studied, although its dependence on specific
acupuncture points was not proven []. In addition, the analgesic effect of acupuncture was shown to be antagonised by
the opioid antagonist naloxone in both mice and humans [,], suggesting that endogenous narcotic(s) might mediate the effect of acupuncture,
as confirmed later by Han []; and
o Many ground-breaking TCM-inspired discoveries date back to this period of time,
including the award-winning discoveries of the anti-malaria drug artemisinin from
the Chinese plant Artemisia annua L. by Youyou Tu and co-workers [-], the isolation of the anti-cancer compound camptothecin from Camptotheca acuminata Decne, by Monroe Wall, Mansukh Wani and co-workers [,]. Also arsenic trioxide was discovered during this time as a new adjuvant treatment
for leukaemia [].
Phase II (s)
This phase was especially characterised by the following main hallmarks:
o In 1985, China’s State Administration of Traditional Chinese Medicine (SATCM) was
established and it has since coordinated actions nationally and played an active role
internationally on TCM-
o In 1998, the American Chemical Society granted Monroe Wall the Alfred Burger Award,
the most prestigious prize in medicinal chemistry and, in 2000, he and Mansukh Wani
won the Charles F. Kettering Prize, an international award, from the General Motors
Foundation for the discovery of camptothecin and taxol, two ground-breaking natural
products with anti-cancer activity []; and
o In 2003, China's National Science & Technology Progress Award honoured Keji Chen,
Lianda Li and colleagues in the China Academy of Chinese Medical Sciences with a top
category award for their successes in TCM treatment of cardiovascular diseases.
During this thirty-year phase, China’s national TCM network continued to grow, along
with international outreach, and to integrate with Western medicine. The latter has
been coordinated by the Chinese Association of Integrative Medicine since late 1981.
By the 1990s, China had almost 3,000 dedicated TCM hospitals and over 95% of Western
medicine hospitals in China had fully-fledged TCM wards and ou
outside China, TCM was practised by more than 300,000 practitioners in over 140 countries
[]. In 1991, the first university related TCM hospital was opened in Koetzting, Germany,
as a joint venture with Dongzhimen Hospital, Beijing []. Since then, numerous TCM hospitals, clinics and teaching programmes have been established
in Europe and other parts of the world [].
As China’s gross domestic product (GDP) increased from No. 7–10 in the world at the
beginning of the 1980s to No. 2 in 2010, it continued to strengthen its national TCM
teaching and training capacity. By the end of the 2000s, China had 32 higher education
institutions (HEIs) specialising in TCM and additional 52 HEIs with TCM some
270,000 students were in training at all levels []. Spearheaded by the Ministry of Science and Technology, the Ministry of Health and
SATCM, and with support from 16 ministries, China has continuously increased its investment
in the R&D of TCM and promoted international dialogues and collaborations, especially
since the late 2000s [].
Meanwhile, funding bodies outside China also started to increase their support for
research on non-conventional medicines, such as TCM. In 1998, the US National Institutes
of Health established the National Center for Complementary and Alternative Medicine
(NCCAM), dedicated to funding research on complementary and alternative medicines,
including TCM []. With a starting annual budget of 50 million dollars for 1999, the Center’s annual
funding has been in the region of 100–125 million dollars in the past ten years. In
2007, the Australian National Institute of Complementary Medicine (NICM) was established
following the 2003 recommendations by the Expert Committee on Complementary Medicines
in the Australian Health System. This was to provide leadership and support for strategically
directed research into complementary medicine and translation of evidence into clinical
practice and health policy. Initial seed funding for the establishment of NICM in
2007 included 4 million Australian dollars from the Department of Health and Ageing
and 0.6 million Australian dollars from the New South Wales Office for Science and
Medical Research []. In 2005, Austria-based Eurasia-Pacific Uninet and the China Academy of Chinese Medical
Sciences signed the first Memorandum of Agreement on Sino-Austrian collaboration in
TCM research. Following this in 2007, the Sino-Austrian Collaborating Centre for Chinese
Medical Sciences was established in Beijing, with a joint project on TCM and age-related
diseases funded with one million Euro from both the Austrian Federal Ministries of
Health and of Science and Research, together with the China Ministry of Science and
Technology []. In 2009, the European Union (EU) funded ~1 million Euro to the Good Practice in Traditional Chinese Medicine (GP-TCM) Research in the Post-genomic
Era Consortium under its 7th Framework Programme (FP7), in order to coordinate EU-China dialogues and collaborations
in TCM research []. International collaborations in TCM practice, teaching, research and development
were also promoted by new international organisations established in the five years
since 2000, e.g. the International Society for Chinese Medicine, the Modernized Chinese
Medicine International Association, the Consortium for Globalization of Chinese Medicine
and the World Federation of Chinese Medicine Societies, each with distinct strengths
[]. Existing international organisations also took actions. The World Health Organization
(WHO) recognised the importance of TCM, and published Medicinal Plants in China: A Selection of 150 Commonly Used Species in 1989 []. In 2010 it set up a programme to standardise terms used in TCM and its derivatives
such as kampo (Japanese herbal medicines derived from TCM), as the beginning of its efforts to
create an evidence base for traditional medicine and to provide an international platform
to harmonise information exchange on traditional medicines []. The International Organization for Standardization (ISO) set up specialised committees
dedicated to TCM in 2009 []. The United Nations Educational, Scientific and Cultural Organization (UNESCO) inscribed
acupuncture and moxibustion on the Representative List of the Intangible Cultural Heritage of Humanity in 2010 [] and inscribed Ben Cao Gang Mu (Compendium of Materia Medica) and Huang Di Nei Jing (Yellow Emperor's Inner Canon) in the Memory of the World Register one year later
Over the years, international journals and public media sensed the historic opportunities
and challenges in TCM. In the Lancet, for example, a number of aspects of TCM, such as acupuncture [-], TCM diagnostic methods [,], herb-drug and herb-immunoassay interactions [,], as well as therapeutic and sometimes severe adverse effects of TCM drugs and adulterants
[-] were reported. In recognition of the political, historic and cultural impacts on
the development of TCM [,,,], the Lancet highlighted the development of TCM in different countries and regions, characterised
by global perspectives [,,,-].
Governmental and non-governmental efforts within and outside China have coincided
with new breakthroughs in modern science. Especially during the past two decades,
globalisation, digitisation, the use of the internet, “omics” technologies and the
concept of systems biology have provided unprecedented opportunities for international
collaborations and provision of new strategies and powerful tools for revisiting TCM
scientifically. Representative examples to illustrate the main achievements of these
thirty years with international and scientific perspectives are given below.
TCM resources
From 1983 to 1994, China conducted a series of nationwide surveys on the substances
used in TCM practice across the country. According to the official data published
by the SATCM, 11,146 botanical and 1,581 zoological species, as well as 80 minerals
were used []. In 2000, the Complete Collection of Traditional Texts on Chinese Materia Medica was published by the Hua Xia Publishing House, Beijing, China (Figure&). In 410 volumes and more than 246,000 pages, more than 800 classic monographs are
included, making it the most comprehensive compilation of TCM and Chinese materia
medica classics dating back to 220 BC - 1911 AD. This collection not only highlights
the value of TCM as a rich source for knowledge-based medical rediscovery due to its
continuous documentation of clinical experiences for thousands of years, but also
implies the huge task to dissect out the very best parts of TCM for modern innovation.
The recognition of the need to standardise materials used in TCM is evidenced in the
nine editions of the Chinese Pharmacopoeia, with each edition containing updated information
about the medicinal products used in TCM. In its latest edition published in 2010,
Volume I is fully dedicated to TCM drugs, representing the most comprehensive official
monographs in this field. Peigen Xiao, the founding director of the Institute of Medicinal
Plant Development in Beijing, was a pioneer in systematic studies of TCM resources,
especially Chinese medicinal plants. He built bridges between Chinese and Western
pharmacognosy and introduced Chinese medicinal plants to the rest of the world. His
work resulted in the discovery of new species and the publication of hundreds of scientific
papers and more than 25 books, e.g. [-]. In response to the European use of TCM products, Hildebert Wagner, Rudolf Bauer
and Peigen Xiao started a joint project in 1995 to elaborate chemical fingerprint
analytical methods for the identification of Chinese herbs in Western pharmacies,
leading to the publication of two volumes of books []. In 2008, the European Pharmacopoeia Commission set up a specialised committee dedicated
to TCM and started to draft monographs on TCM herbs []. The US Pharmacopoeia has also included some Chinese herbs in their monographs.
TCM has continuous records of thousands of years. A. The Complete Collection of Traditional Texts on Chinese Materia Medica in the Hong Kong Baptist University L B. Cover image of the volume one. Photos were taken in November 2011 by Professor Zhongzhen
Zhao, School of Chinese Medicine, Hong Kong Baptist University, China.
Efficacy and effectiveness of Chinese herbal medicine
In the 1990s, randomised, controlled clinical trials began to successfully investigate
claims for a series of TCM drugs. Atherton and colleagues conducted a series of such
trials in the UK, investigating the efficacy of a TCM formula in the treatment of
atopic eczema [,]. In Japan, double-blind placebo-controlled trials showed two kampo drugs to be both safe and efficacious in the treatment of constipation and perennial
nasal allergy []. In Australia, two TCM products were shown to be efficacious in the treatment of
irritable bowel syndrome and hepatitis C [,]. These clinical trials, among others, set important milestones for the overseas use
of Chinese herbal medicine. In 2003, Kanglaite, a botanical drug derived from Coix lacryma-jobi L. seeds became the first drug derived from a TCM herbal remedy to go into clinical
trials in the USA []. Subsequently, many TCM-derived products developed in China (such as Dantonic(R) for
chronic stable angina pectoris and Fuzhenghuayu(R) for liver fibrosis) or the USA (PHY906(R)
as an adjuvant cancer remedy) have been approved for clinical trials by the US Food
and Drug Administration (FDA). In 2010 it was estimated that approximately 25% of
botanical investigational new drug (IND) applications submitted to the FDA were derived
from TCM herbs []. On the other hand, according to Cochrane and other independent reviews, many clinical
trials on TCM were inconclusive, at least partially because of the low quality of
many trials conducted in China []. Similarly, the quality of systematic reviews and data meta-analysis has also been
criticised []. This situation is about to change. Since the mid-2000s, China has accelerated its
steps in joining the international community of evidence-based medicine and clinical
trials conducted in China have begun to be published in leading clinical journals
[,,]. Nevertheless, many challenges remain []. Some challenges are specific to TCM including the practice of personalised medicine
and the difficulties in designing quality controls for TCM practices and drugs, about
which international collaborations such as GP-TCM have led to the development of practical
guidelines [,].
Adverse effects of Chinese herbal medicine
By contrast with the highly regulated field of Western drugs, for which safety is
a paramount preoccupation, the many centuries of traditional use of so-called “natural
products” is, for the general public, often erroneously believed to be innocuous because
they are “natural”. Traditional use, however, is only an indication but certainly
not a proof of safety as dreadful mid-term and long-term toxicities have a low chance
of being detected []. This is being increasingly recognised since 1993 when Vanherweghem and colleagues
reported rapidly progressive interstitial renal fibrosis in women who had followed
a slimming regimen inadvertently containing Aristolochia sp roots. Aristolochic acids were identified as mediators of not only the Aristolochia-induced renal fibrosis, the endemic Balkan nephropathy, but also Aristolochia-induced urothelial cancer [,]. In 1995, the Victorian Department of Human Services and the Health Departments of
New South Wales and Queensland in Australia commenced a review in order to assess
the risks and benefits associated with the practice of TCM []. These studies, together with some other reports, such as those on herb-drug interactions
[], aconite poisoning [] and the hepato- and genotoxicity of pyrrolizidine alkaloids [], gave an impetus to research the adverse effects of herbal medicines. Given the number
of herbal products on the market and relatively low budgets available for research
so far, safety assessment has been carried out on relatively few herbs according to
modern guidelines []. This emphasises the importance of pharmacovigilance in detecting any unfortunate
adverse events [,].
Legislation and regulation of Chinese herbal medicine
Given the importance of ensuring quality of TCM drugs and safety of patients, legislation
and regulation of TCM practitioners and products are equally important. In particular,
the approval of a green tea extract (Veregen(R)) as a drug in the USA and some European
countries indicates that, although “new” botanical drugs pose many challenges for
both industry and regulatory agencies, standardisation and stringent regulation of
these complex drugs are achievable []. In the EU, the Committee on Herbal Medicinal Products (HMPC) of the European Medicines
Agency (EMA) regulates the use of herbals and publishes herbal monographs and lists,
which present a documented scientific opinion on the safety and efficacy data of herbal
substances and their preparations intended for medicinal use []. Specifically, the HMPC evaluates scientifically all available information including
non-clinical and clinical data but also documents long-standing use and experience
in the EU. Due to the different approaches from those used by the FDA, the European
HMPC adopted practical and relevant guidelines, which have brought back hundreds of
herbals to the pharmaceutical standards of quality as approved drugs, under the “well-established”
and “traditional” registration schemes, while the FDA approved so far only a few.
Dobos and co-workers gave an overview of the status of regulations in the USA, the
UK, Germany, Australia and China in 2005 []. The different approaches of regulating herbal products have been also recognised
as an important issue by the FP7 GP-TCM Consortium, which compiled a more comprehensive
global comparison of herbal regulation practices in order to promote harmonisation
in the future [].
Quality control and standardisation of Chinese herbal medicine
For the future development of TCM, raw materials must be produced in a sustainable
way. Cultivation under good agricultural practice (GAP) should be the goal [,]. The scientific principles of daodi should be also considered – Daodi medicinal materials are those produced and assembled in specific geographic regions
with designated natural conditions and ecological environment, with particular attention
to cultivation technique, harvesting and processing, and thus regarded as superior
in quality and effects as compared to materials of the same species obtained from
other regions []. The identity and pharmaceutical quality of herbal medicinal products must be controlled
in Europe and China according to the pharmacopoeia standards []. Due to the complex chemical composition of TCM drugs and many sources of variations
that could lead to batch-to-batch inconsistency, classical quality control measures
such as those applied to purified chemical drugs are often not suited to ensure quality
of TCM materials and products. Sometimes DNA based methods may be needed for unambiguous
authentication [], but do not yield any information on the qualitative and quantitative chemical profiles.
In order to focus not only on single quality marker compounds, more holistic concepts
need to be developed such as metabolic fingerprinting [,]. Incorporating state-of-the-art analytical methodologies, including liquid chromatography
/ mass spectrometry (LC/MS), for chemical characterisation and chemical fingerprinting,
differential cellular gene expression for bioresponse fingerprinting and animal pharmacology
for in-vivo validation, PhytomicsQC, a proprietary comprehensive platform for quality control
of botanical drugs was developed to ensure batch-to-batch consistency of a standardised
TCM formula PHY906(R) []. The FP7 GP-TCM Consortium have recognised authentication and quality control of
research materials used in clinical, animal and in-vitro studies as an area that needs urgent improvement and have developed a checklist and
good practice guidelines [,]. Funding bodies, journals, academia and commercial suppliers must collaborate closely
to address this fundamental issue. Post-harvest treatment and processing (paozhi) are common features in Chinese herbal medicine. In order to provide plant material
of consistent quality, these processes need to be scientifically investigated and
standard operating procedures and specific endpoints need to be defined and implemented
Mechanisms and herbalome
Beyond the success in isolating new chemical entities amenable to drugs, such as artemisinin,
emerging evidence suggested that multiple compounds from herbals might demonstrate
synergism. In vitro, the antimicrobial action of berberine was potentiated by multidrug pump inhibitors
biosynthesised by the same plants that produce berberine or by different plants [,]. In acute promyelocytic leukaemia (APL) animal models and in APL cell lines, synergism
among three active compounds isolated from the three components of a TCM formula was
also demonstrated []. In addition, Yung-Chi Cheng’s team at Yale University successfully combined animal
studies, clinical studies and genomics technology to elucidate the mechanisms of PHY906(R)
as a cancer adjuvant therapy and demonstrated that all four herbs in the PHY906(R) formulation
were necessary for its biological effects [-]. In 2008, the “Herbalome Project”, an ambitious 15-year effort was launched in China
to clarify the chemical composition, structure and function of commonly used Chinese
herbs and TCM formulae, to establish a standard resource library, and to interpret
the synergistic and complementary mechanisms of multiple components in TCM drugs on
multiple targets [,]. Until recently, the project focused on development of systematic separation methodology
for resolving and analysing the complex components in Chinese herbal medicine and
establishment of a comprehensive resource library []. This project might eventually help to understand the chemical basis of the active
constituents of TCM drugs, be they single or multiple compounds.
Acupuncture
Clinical trials on treatment of pain and other diseases, adverse effects, mechanisms
of action and discussions on the roles for the placebo effect in acupuncture continued
to be active. Earlier reports of adverse effects were usually related to insufficient
basic medical knowledge, low hygienic standard and inadequate acupuncture education
[]. With disposable sterile needles and improved training and regulation of acupuncturists,
more recent data from large surveys in the UK [,] and Germany [,] have shown that adverse events after acupuncture are uncommon and acupuncture is
a safe therapy in the hands of well trained professionals. A placebo needle that does
not penetrate the skin was introduced for sham acupuncture [], a plausible tool to differentiate placebo effects caused by non-penetrating sham
acupuncture [,]. A number of large-scale trials on the efficacy [-] and effectiveness [,] of acupuncture, as well as randomised controlled trials on the efficacy of combined
therapy of acupuncture and Chinese herbal medicine [], a recent meta-analysis, that pooled the data of 29 clinical
trials on chronic pain, concluded that acupuncture is statistically superior to sham
acupuncture []. However, debates about acupuncture point specificity, acupuncture techniques and
placebo effects will likely continue. Nevertheless, a growing body of evidence had
clinical implications. For example, in 2006, the German health authorities decided
to include acupuncture in routine reimbursement by social health insurance funds for
chronic low back pain and chronic osteoarthritis of the knee []; in 2009, the UK National Institute for Health and Clinical Excellence (NICE) issued
a guidance on the treatment of low back pain, suggesting that doctors should ‘consider
offering a course of acupuncture needling comprising a maximum of 10 sessions over
a period of up to 12 weeks’ for their patients []; and in 2012, NICE published a new guideline on the diagnosis and management of headaches
in young people and adults, which suggested that healthcare professionals should consider
offering patients a course of up to 10 sessions of acupuncture, administered over
a period of from five to eight weeks, for the prophylactic treatment of chronic tension-type
headaches [].
A number of physiological changes were documented as consequences of acupuncture needling,
which might direct to possible mechanisms of action of acupuncture. In particular,
a novel hypothesis for the physiological basis of acupuncture involving purinergic
signalling was proposed, where adenosine-5’-triphosphate (ATP), released in the skin
during acupuncture, acts on purinoceptors on sensory nerve terminals and, through
interneurons, interrupts pain pathways and modulates motor nerve activity in the brain
stem, regulating autonomic functions []. This was followed by a paper suggesting that adenosine, after breakdown of ATP in
the skin, acted as a prejunctional modulator of nociceptive sensory pathways [].
The start of phase III () and the future
The start of Phase III coincided with the announcements of three prestigious international
awards for scientists involved in different aspects of TCM research [-]:
o The 2011 Lasker-DeBakey Clinical Medical Research Award honoured Youyou Tu for the discovery of the anti-malaria drug artemisinin [-];
o The 7thAnnual Szent-Gy?rgyi Prize (2012) was awarded to Zhen-Yi Wang and Zhu Chen for their ground-breaking research
of arsenic trioxide treatment of leukaemia back in the 1990s []; and
o The 1stCheung On Tak International Award for Outstanding Contribution to Chinese Medicine (2012) was shared by Keji Chen for his pioneering research in TCM treatment of cardiovascular
diseases [,] and to Yung-Chi Cheng for developing a classical TCM formula into a standardised
modern cancer adjuvant therapy [].
In October 2012, another highlight of the beginning of phase III was the final outputs
from the FP7 GP-TCM project, which brought together a large collaborative network
of over 200 scientists and clinicians, more than 100 institutions and 24 countries
to work on the future directions of TCM. The main conclusions of this FP7 project
were published in a special open-access issue of the Journal of Ethnopharmacology, in which good practice was defined, guidelines collated, information updated and
priorities, challenges and opportunities agreed []. To sustainably develop, refine and disseminate good practices in TCM research beyond
the FP7 GP-TCM project, the GP-TCM Research Association was founded in April 2012
The advice from the FP7 GP-TCM project to the TCM scientific community can be summarised
by the need for more:
o Integrity: In the scientific context of TCM, integrity is defined as good practice
and rigour, a concept of consistency of actions, values, methods, measures, principles,
o Integration: The word refers to an approach towards wholeness by either bringing
parts together or
o Innovation: The word refers to renewal or change, as well as introducing better
or more effective products, processes, services, technologies, or ideas, etc.
These concepts are further expanded and interpreted below.
1. Integrity
o Holism. As a holistic medicine, TCM considers the human body as a whole, emphasises the importance
of functions and emotions and considers patients as part of a system interacting with
its environmental factors, such as diet, climate and life style. This is embodied
in TCM diagnosis, prescriptions and life style interventions.
o Ethics. Since the era of Sun Simiao (581–682 A.D.) ethics has become an integral part of
TCM []. In ancient China, practitioners’ ethics were at the centre of the TCM profession.
Now, TCM ethics should apply to not only TCM practitioners, but also the agricultural,
industrial and scientific communities, and all stakeholders. Conflict of interests
should be avoided, stated and properly regulated.
o Good practice. As promulgated by the FP7 GP-TCM project and the GP-TCM Research Association, TCM
requires continuous development, refinement and dissemination of good practice guidelines
in all its multiple aspects. In such epic efforts, collaboration and sharing must
be encouraged and we must strive for consensus while respecting differences. Good
practice is especially required in authentication, quality control, safety assessments
and sustainable use of TCM agricultural and man
commercial an basic and clinical research of TCM; application
of routine and e as well as differentiation between valuable
knowledge and superstitious, erroneous and misleading anecdotes [,].
2. Integration
o Education, clinical practice and research. Integration of these three important aspects was one of the most important achievements
in modernisation of TCM and this must continue.
o Cultural, philosophical and scientific perspectives. TCM is an important part of Chinese culture and is guided by Chinese philosophy.
Thus, researchers of the scientific, cultural and philosophical values of TCM should
collaborate with and learn from each other.
o TCM, Western medicine and modern science. In China and some other countries, TCM and Western medicine are both in mainstream
healthcare and intend to complement each other. In the international context, dialogue
between TCM and Western medicine
China’s experiences and lessons
should be studied in light of modern science so that both medical traditions may contribute
to forging tomorrow’s medicine. Bringing evidence-based medicine to recognise the
value of TCM will have to integrate a thorough rethinking of both Western and TCM
practices to generate scientifically and statistically convincing evidence of the
TCM-based approaches.
o Interregional, intersectoral and interdisciplinary collaborations. Due to the complexity and the vast range of TCM, collaborations between different
regions, different business sectors, as well as different areas of knowledge must
be encouraged in order to share resources and expertise and join forces to meet the
challenges together. For example, the various distribution channels encountered in
different countries must be connected in order to develop harmonised pharmacovigilance
procedures suitable to rapidly and globally detect and assess warning signals for
adverse events.
o Holistic, relationist and analytical, reductionist approaches. TCM emphasises holistic and relationist approaches of thinking, while Western medicine
is largely based on analytical and reductionist approaches. To see both the trees
and the wood, these approaches must be integrated.
o Quality, toxicology and pharmacology. These three most important aspects of TCM are so much interrelated that future training
and research must further integrate these crucial elements to better ensure safety
and efficacy.
3. Innovation
o Modernisation of TCM is more than Westernisation. Although some achievements have already arisen through studying TCM using a Western
approach, e.g. isolating pure compounds, real innovations should include both TCM-inspired
changes in mode of thinking and practice in Western medicine and TCM refinements inspired
by modern science.
o TCM diagnosis. Among all aspects of TCM, holistic TCM diagnosis has probably the most complementary
elements to modern medical practice, including its function-oriented description of
organ systems and diagnostic approach (leading to syndrome differentiation), its emphasis
on modulation of functional balance, its comprehensive categorisation and interpretation
of tongue and pulse patterns, its characteristic categorisation of the nature of diseases
and drugs, etc. These could be important sources for developing and validating innovative
mindset, methods, tools and strategies that could complement biology-based diagnosis
o Preventive and comprehensive interventions. TCM is characterised by both pre-emptive approaches and interventions with multiple
components. It emphasises intervention before disease arises and often combines dietary
advice, physical exercises such as Taijiquan (Tai Chi Chuan) [,], meditation, herbal medicines, massage, acupuncture and moxibustion, etc. The values
of these individualised and integrated approaches are important directions for future
public health.
o Innovative, more robust theories and methodology. The complexity of TCM demands novel and more robust ways of thinking, approaches,
tools and methods. For example, the individualised and holistic nature of TCM requires
tools for complexity research, research of the science of individuality and personalised
medicine, as well as novel statistics []. It also awaits the maturation of omics, systems biology and other systems-based
technologies [].
o Prioritisation and focus. In view of the vast areas of TCM yet to be explored and the limited resources available
for such an emerging area of research in the global context, prioritisation and focus
become the key to achieving real innovation. In this regard, a Steve Jobs approach
for innovation is to “say no to 1,000 things”[] and to focus only on those that could make real differences becomes all the more
compelling.
Conclusions
After 60 years of development, modernisation of TCM has arrived at a new era. Accumulating
evidence supports the notion that this new era represents a golden opportunity for
TCM to further consolidate its scientific base so as to play a bigger part in forging
tomorrow’s medicines. To achieve this, especially to reach the goals of better quality,
safety and efficacy, the proposed rules of integrity, integration and innovation must be followed.
Abbreviations
APL: Acute pro ATP: Adenosine-5’- EMA: The European
Medicines A EU: European U FDA: The Food and Drug Administration of the
United S FP7: The 7th Framework P GAP: Good Agricultural P
GDP: Gr GP-TCM: Good Practice in Traditional Chinese M
HEIs: Higher ed HMPC: The Committee on Herbal Medicinal P
IND: Inve ISO: International Organization of S
LC: L MS: M NCCAM: The National Center for Complementary
and Alternative Medicine of the United S NICE: The UK National Institute for
Health and Clinical E NICM: Australian Natural Institute of Complementary
M R&D: Rese SATCM: State Administration of Traditional
Chinese Medicine of C TCM: Traditional C UNESCO: The United Nations
Educational, Scientific and Cultural O UK: United K USA: United
States of A WHO: The World Health Organization
Competing interest
The authors declare that they have no competing interests.
Authors’ contributions
QX contributed to the overall conceptualisation and project plan, coordinated various
sections of the paper, synthesised the findings and coordinated the writing of the
paper. RB contributed to the overall writing and revision, especially on milestones
outside China and in sections on TCM resources, quality control and standardisation.
PJH and BMH contributed to the overall conceptualisation, synthesised the findings
and played central roles in discussion and revision of the manuscript. T-PF contributed
to the overall revision and provided some very critical references and ideas. ZZ provided
the photo used in Figure& and contributed to the writing of the TCM resources section. PD contributed to the
writing and critical revision of the whole manuscript, especially the toxicology section.
CMW and NR gathered literature and information and wrote part of the acupuncture section,
as well as contributed to the overall discussion and revision process. MSJS did literature
analysis for the whole paper and contributed to the overall discussion and revision
of the manuscript. AL provided information on clinical TCM and integrative TCM studies
and wrote part of the contents of the paper. DG provided some useful discussions and
revisions on the manuscript. All authors read and approved the final manuscript.
Authors’ information
QX is Senior Lecturer in Renal Medicine and Co-Director of the King’s Centre for Integrative
Chinese Medicine at King’s College London. He was the Coordinator of the FP7 GP-TCM
Project and is Vice President of the GP-TCM Research Association. RB is Professor
of Pharmacognosy, Head of the Institute of Pharmaceutical Sciences at University of
Graz, Head of TCM Research Center Graz, member of the European Pharmacopoeia TCM Working
Party, and President of the GP-TCM Research Association. BMH is Professor of Renal
Medicine at King’s College London and President-elect of the Renal Association, UK.
T-PF is Senior Lecturer and Head of Angiogenesis and Chinese Medicine Laboratory in
the Department of Pharmacology, University of Cambridge. He was Deputy Coordinator
of the FP7 GP-TCM Project and Coordinator of its R&D and Regulatory Work Package,
and is Secretary-General of the GP-TCM Research Association. AL and ZZ, Professors
of TCM, are respectively Dean and Associate Dean of School of Chinese Medicine, the
Hong Kong Baptist University. PD is Professor of Pharmacognosy at Université Libre
de Bruxelles and Université de Mons, member of the European Pharmacopoeia TCM Working
Party, and was Co-Coordinator of the Toxicology Work Package of the FP7 GP-TCM Project.
CMW is Professor of Medicine and Acting Director of Institute for Social Medicine,
Epidemiology and Health Economics at Charité-Universit?tsmedizin Berlin. NR is Professor
of TCM and Integrated Health at the London South Bank University and was Co-Coordinator
of the Clinical Studies of Chinese Herbal Medicine and Acupuncture Work Packages of
the FP7 GP-TCM Project. MSJS is Director of the Kew Innovation Unit, Deputy Keeper
& Head of Sustainable Uses of Plants Group at Royal Botanic Gardens, Kew, and was
Coordinator of the Quality Control Work Package of the FP7 GP-TCM Project. DG is Chair
Professor of Pharmacognosy and Director of Center for TCM Modernization, Shanghai
Institute of Materia Medica, Chinese Academy of Sciences. He was Deputy Coordinator
of the FP7 GP-TCM Project and is President-elect of the GP-TCM Research Association,
and chairs the Natural Medicine Expert Committee of the Chinese Pharmacopoeia and
sits on the Expert Committee of the United States Pharmacopeia. PJH is Professor of
Pharmaceutical Chemistry, Director of the Institute of Pharmaceutical Science and
Co-Director of the King’s Centre for Integrative Chinese Medicine at King’s College
London. He was Coordinator of the In-Vitro Pharmacology Work Package and chaired the Technological Advisory Board of the FP7
GP-TCM Project and is a member of the Expert Advisory Group on Herbal Medicinal Products,
British Pharmacopoeia Commission. QX, RB, T-PF, PD, MSJS, AL, NR, DG and PJH are members
of the Board of Directors of the GP-TCM Research Association.
Acknowledgements
All authors are beneficiary or non-beneficiary members of the FP7 GP-TCM project,
which was funded by the EU under the grant agreement No. 223154. We thank all project
members for their contributions that have inspired this manuscript and in particular,
we gratefully acknowledge the following colleagues for their critical discussions
on this manuscript: Professor Geoffrey Burnstock, FRS (University College London,
UK), Professor Xinmin Liu, Professor Jingyuan Song and Professor Shilin Chen (Institute
of Medicinal Plant Development, Chinese Academy of Medical Sciences, China), Professor
Olavi Pelkonen (University of Oulu, Finland), Dr. Halil Uzuner (King’s College London,
UK; currently working at Royal Botanic Gardens, Kew, UK), Professor Rob Verpoorte
and Professor Jan van der Greef (Leiden University, The Netherlands) and Professor
Elisabeth M Williamson (University of Reading, UK).
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